Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-07-19

Brief Summary

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This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.

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Detailed Description

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Surgical wound closure with nonabsorbable stitches necessitates subsequent suture removal, a process that can be uncomfortable for the patient and consume clinic time and resources. Anecdotal evidence suggests that the addition of a vessel loop under the sutures both simplifies suture removal and reduces discomfort. In this study, we propose a prospective, randomized, controlled, superiority trial to assess the impact of a vessel loop wound closure and suture removal for elective carpal tunnel release (CTR). Patients will be prospectively enrolled to one of two groups: closure without a vessel loop or closure with a vessel loop. The primary outcome measure will be patient satisfaction with suture removal. Time for wound closure, time for suture removal, pain with suture removal and other patient reported outcomes will be measured. These data will allow us to determine the benefit of addition of a vessel loop in wound closure.

Conditions

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Patient Satisfaction Suture, Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who agree to participate will be enrolled and randomized to one of two study groups:

* Group 1: Incision closure without a vessel loop.
* Group 2: Incision closure with a vessel loop.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closure without vessel loop

These patients will receive standard of care closure of the carpal tunnel release incision.

Group Type NO_INTERVENTION

No interventions assigned to this group

Closure with vessel loop

These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures.

Group Type EXPERIMENTAL

Vessel loop (FDA product code FZZ)

Intervention Type DEVICE

The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.

Interventions

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Vessel loop (FDA product code FZZ)

The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective primary CTR (CPT 64721) at Carilion Clinic for carpal tunnel syndrome (CTS) diagnosed by CTS-6 or electrodiagnostic studies (EDS).

Exclusion Criteria

* Emergency procedures.
* Revision procedures.
* Bilateral procedures.
* Concomitant procedures.
* Inability to provide informed consent for the study.
* Non-native English speakers.
* Allergy to suture material.
* History of wrist trauma.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No